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PI RISK & IMPLICATIONS

Despite standard Ig therapy, patients continue to experience recurrent respiratory infection and chronic lung disease1,2

 

Risk factors that complicate the approach to PI and impact survival include:

Lung Disease: >90% of PI patients on standard IVIG experience recurrent respiratory infection and chronic lung disease | Among a large cohort of patients with PI receiving standard Ig therapy (N=3125) 52% developed COPD/asthma | In a 40-year study of 473 patients with PI 29% developed chronic lung disease, 11% developed bronchiectasis
Lung Disease: >90% of PI patients on standard IVIG experience recurrent respiratory infection and chronic lung disease | Among a large cohort of patients with PI receiving standard Ig therapy (N=3125) 52% developed COPD/asthma | In a 40-year study of 473 patients with PI 29% developed chronic lung disease, 11% developed bronchiectasis
Graphic showing the connection between recurrent infections, bronchiectasis, inflammation, and tissue damage | Additional risk factors include excessive use of antibiotics, history of infection, chronic sinusitis, age, and environmental factors
Graphic showing the connection between recurrent infections, bronchiectasis, inflammation, and tissue damage | Additional risk factors include excessive use of antibiotics, history of infection, chronic sinusitis, age, and environmental factors

Clinical presentation varies across patient populations and may impact treatment decisions

*Other factors that could lead to infection include inflammatory disease, malabsorption, granulomatous disease, liver diseases, including hepatitis, lymphoma, and other cancers.6

Despite standard Ig therapy, patients with PI experience significant reductions in their quality of life8

Recurrent respiratory infections result in significant activity limitations8

  • The latest IDF survey of PI patients shows that despite IGRT, nearly 50% of PI patients still experience significant activity limitations annually

Graphic showing 15% of patients experience severe limitation, 34% experience moderate limitation, 36% experience slight limitation, and 15% experience no limitation
Graphic showing 15% of patients experience severe limitation, 34% experience moderate limitation, 36% experience slight limitation, and 15% experience no limitation
  • Patients continue to miss many days from work/school

Patients with PI require extensive healthcare utilization8

Based on the latest IDF survey of adults with PI, a significant percentage of PI patients annually require the following:

Patients require ≥10 specialty doctor visits
≥20% of patients require hospitalizations
≥82% of patients require antibiotics to treat infection

When selecting an IVIG treatment, individual patient characteristics should be considered

Patients were asked, “During the past 12 months, how much has he/she been limited in work, play, or normal physical activity as a result of his/her health?” Answers were limited to individuals who currently use Ig replacement.
Patients were asked, “Not counting hospitalizations, how many days was the patient too sick to work, go to school, or perform usual activities in the past 12 months?” Answers were limited to individuals who currently use Ig replacement. Those who were retired or too disabled to work were excluded.
IDF=Immune Deficiency Foundation.

Indication

ASCENIV (immune globulin intravenous, human – slra) is a 10% immune globulin liquid for intravenous injection, indicated for the treatment of primary humoral immunodeficiency (PI) in adults and adolescents (12 to 17 years of age). PI includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID).

 

Important Safety Information for ASCENIV™

WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE

  • Thrombosis may occur with immune globulin (IGIV) products, including ASCENIV. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
  • Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of IVIG products in predisposed patients.
  • Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. ASCENIV does not contain sucrose.
  • For patients at risk of thrombosis, renal dysfunction or renal failure, administer ASCENIV at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

References:

  1. Cinetto F, Scarpa R, Rattazzi M, Agostini C. The broad spectrum of lung diseases in primary antibody deficiencies. Eur Respir Rev. 2018;27(149):180019. 

  2. Baumann U, Routes JM, Soler-Palacín P, Jolles S. The lung in primary immunodeficiencies: new concepts in infection and inflammation. Front Immunol. 2018;9:1837.   

  3. Jolles S. Subclinical infection and dosing in primary immunodeficiencies. Clin Exp Immunol. 2014;178(suppl 1):67-69.

  4. Dilley M, Wangberg HW, Noone J, Geng B. Primary  immunodeficiency diseases treated with immunoglobulin and associated comorbidities. Allergy Asthma Proc. 2021;42:78-86. 

  5. Resnick ES, Moshier EL, Godbold JH, Cunningham-Rundles C. Morbidity and mortality in common variable immune deficiency over 4 decades. Blood. 2012;119(7):1650-1657. 

  6. Johnson D. Common variable immunodeficiency: a clinical overview. Clinician Reviews. 2017;27(6):38-42. 

  7. MacGillivray DM, Kollmann TR. The role of environmental factors in modulating immune responses in early life. Front Immunol. 2014;5:434. 

  8. Immune Deficiency Foundation. 2018 National Treatment Survey. Accessed February 13, 2023. https://www.primaryimmune.org/sites/default/files/IDF-2018-Treatment-Survey.pdf